Cadila and Kalbe advancing biosimilar ambitions
Posted 09/03/2018

Indian generics maker Cadila Healthcare (Cadila) and Indonesia-based Kalbe Farma (Kalbe) are both making advances into the biosimilars field.

Cadila, part of the Zydus Cadila group, announced on 27 February 2018 that it was carrying out a phase I clinical trial for its pegfilgrastim similar biologic, where it will be tested on healthy volunteers for safety.

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Cadila says that it is planning to file for approval of its first similar biologic (pegfilgrastim) in the US by the end of 2019. The company expects its ‘biosimilars business to have the potential to touch US$500 million in next 5 to 7 years from the US$45 million that it makes currently’.

Kalbe, on the other hand, announced on 27 February 2017 the inauguration of its factory in Cikarang, West Java, which will produce biotechnology-based medicines. The factory will be managed through subsidiary PT Kalbio Global Medika and is expected to reduce Kalbe’s dependency on imports for its drug production.

According to Kalbe, the first copy biological to be produced at the factory will be erythropoietin, a hormone secreted by the kidney that stimulates red blood cell production to help battle cancer, kidney failure and anaemia. Once erythropoietin products enter the market by the end of 2018, Kalbe intends to start production G-CSF, followed by the production of insulin and monoclonal antibodies.

As well as trying to capture the Southeast Asian market, Kalbe also plans to expand its business to Sri Lanka and the Middle East in an effort to increase exports by 10% in the next five years, up from 6% currently.

Editor’s commentIt should be noted that ‘similar biologics’ approved in India and ‘copy biologicals’ approved in Indonesia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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